ECC Quadrox iD w/RF 3/8" 701065958

GUDID 00607567208544

BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 800ml Blood Transfer Bag 1000 ml - 2 spike ports BEQ-RF32 RotaFlow CDI Sat Cell 3/8" System 100 Blood Microfilter System SQ 40 S Prebypass filter w/o Vent Porous Media 3/8x3/8 Gas Filter

DATASCOPE CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00607567208544
• NIH Device Record Key: 638bcf03-a757-4ad4-8386-0708418e703d
• Commercial Distribution Discontinuation: 2017-04-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ECC Quadrox iD w/RF 3/8"
• Version Model Number: BEQ-TOP 47001
• Catalog Number: 701065958
• Company DUNS: 001660786
• Company Name: DATASCOPE CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567208544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080592

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

[00607567208544]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-01-29

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